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Aesculap Implant Systems LLC recalls Aesculap Sterile disposable fleece drape, Product code: GA414, individually packaged, 50 pieces per shipping unit, produ
Recalled July 27, 2022 · FDA recall Z-1449-2022 · Aesculap Implant Systems
Hazard
Packaging seal integrity not validated resulting in a lack of sterility assurance. · FDA Class II
Units
4500 pieces
Sold at
United States: CA, CO, GA, IL, IN, KY, MI, NC, NE, NY, OH, RI, VA and WI
Description
Packaging seal integrity not validated resulting in a lack of sterility assurance.
Product
Aesculap Sterile disposable fleece drape, Product code: GA414, individually packaged, 50 pieces per shipping unit, product code SZ380R.
Manufacturer(s)
Aesculap Implant Systems LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →